AcrySof® UltraSert® ACU0T0 (REF ACU0T0.245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652395342), received between Oct 28, 2021 and Dec 5, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DOES NOT UNFOLD, REMAINS STRAIGHT, WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725428 ↗
• MalfunctionNov 18, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THE DAMAGE OF INJECTOR IN THE BEGINNING OF THE INSERTION OF THE LENS INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581033 ↗
• MalfunctionNov 5, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DISTAL HAPTIC WAS FOUND TO BE BROKEN PRIOR TO IMPLANTATION. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION RECEIVED STATING THAT SURGERY WAS COMPLETED WITH ANOTHER BACKUP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482565 ↗
• MalfunctionApr 17, 2025Failure to Advance; Failure to Advance

  NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER MISSED INTRAOCULAR LENS, PLUNGER WENT OVER LENS, DID NOT ENGAGE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855893 ↗
• MalfunctionMar 26, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE WAS FAULTY, HAPTIC WAS NOT FOLDED WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THERE WAS NO PATIENT HARM.. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699475 ↗
• MalfunctionFeb 6, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC STUCK IN THE INJECTOR WHILE ADVANCING THE LENS INTO THE EYE. THE LENS WITH ONE HAPTIC WAS INSERTED INTO THE EYE DUE TO THE HAPTIC BREAKING OFF DURING THE INSERTION PROCESS, LENS HAPTIC REMAINS IN THE DELIVERY SYSTEM AND WAS CAUGHT ON THE BLUE PLUNGER. THE SURGERY WAS COMPLETED BY USING ANOTHER LENS OF SAME DIOPTER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT HARM. THE PATIENT HAD TO HAVE THE LENS REMOVED FROM THE EYE. PATIENT ISSUES WERE RESOLVED, THE SURGERY WAS LONGER AND THEN A NEW LENS WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322326 ↗
• MalfunctionJan 18, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS CRACKED WHEN IT UNFOLDED. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME SURGERY. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534196 ↗
• MalfunctionAug 2, 2023Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS CAME DEFECTIVE INTO THE EYE DURING IMPLANTATION.ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17441188 ↗
• MalfunctionMar 22, 2023Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION LENSES CAME OUT OF THE INJECTOR WITH THE FRONT HAPTIC STRETCHED ALSO THE LENSES WERE EVEN DEFECTIVE AT THE TRANSITION FROM OPTIC TO HAPTIC. THE SURGERIES COULD BE COMPLETED NORMALLY. FROM TIME TO TIME, THE LENS HAD TO BE EXPLANTED AND A NEW ONE IMPLANTED BECAUSE OF THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 4.

  Patient problems: Insufficient Information

  MAUDE report 16592987 ↗
• MalfunctionOct 21, 2022Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available; Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF THE LEADING HAPTIC WAS STRAIGHT OUT IN FRONT OF THE IOL (INTRAOCULAR LENS) AT THE BEGINNING OF THE NOZZLE OF THE DELIVERY SYSTEM AND NOT FOLDED. THE REAR HAPTIC APPEARED TO BE FOLDING FORWARDS CORRECTLY, BUT THE IOL APPEARED TO BE OPENED OUT AND POTENTIALLY NOT FOLDING INTO THE NOZZLE OF THE DELIVERY SYSTEM CORRECTLY. THERE APPEARED TO BE SOME DAMAGE STARTING AT THE REAR OF THE IOL THAT HAD BEEN CAUSED BY THE PLUNGER.

  Patient problems: Insufficient Information

  MAUDE report 15650194 ↗
• MalfunctionAug 23, 2022Failure to Fold; Defective Device; Failure to Eject; Failure to Fold; Defective Device; Failure to Eject

  A NON-HEALTH PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES SEEM TO BE TOO HARD AND WERE NOT COMING OUT IN THE CORRECT POSITION. ADDITIONAL INFORMATION WAS RECEIVED STATING THE TIP OF THE LENS DISPENSER CAME INTO CONTACT WITH THE PATIENT BUT THERE WAS NO HARM DONE TO THE PATIENT. IN REGARD TO LENSES NOT COMING OUT IN THE CORRECT POSITION, WE RECEIVED CLARIFICATION AND IT REFERS TO THE LENSES WOULD GET STUCK ON THE TIP OF THE DELIVERY DEVICE AND THEN GO BACK IN, SURGEON ASSUMES IT¿S BECAUSE THE LENSES WERE NOT FOLDING PROPERLY OR THE LENSES WERE TOO HARD. ALL PROCEDURES WERE DONE WITH BACK-UP LENSES. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277988 ↗
• MalfunctionMar 30, 2022Defective Device; Defective Device

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS AN INJECTOR FAILURE ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT THERE WAS A PATIENT CONTACT. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED. THE SURGEON PROGNOSIS WAS GOOD. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950188 ↗
• MalfunctionOct 28, 2021Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711302 ↗